Italian Medicines Agency Agenzia Italiana del Farmaco

AIFA publishes CTS opinion on monoclonal antibodies - AIFA publishes CTS opinion on monoclonal antibodies

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AIFA publishes CTS opinion on monoclonal antibodies

AIFA publishes the opinion of its Scientific-Technical Committee (CTS), which met in extraordinary session on 2, 3 and 4 February 2021, on the use of monoclonal antibodies.

As stated in the opinion, adopted on 4 February 2021, "the CTS, while considering data immaturity and the consequent uncertainty as for the extent of the benefit offered by these drugs, believes, by a majority, that in exceptional cases and in view of the emergency situation, it may still be appropriate to offer a therapeutic option to non-hospitalized subjects who, despite having a mild/moderate disease, are at high risk of developing a severe form of COVID-19 with a consequent increase in the probability of hospitalization and/or death. In particular, it is a risk setting for which no standard treatment of proven efficacy is currently available".

This opinion, published on the institutional portal, has been provided to verify the possible methods of use of such medicinal products within the NHS.


Published on: 05 February 2021

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